Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of inclisiran (Leqvio) may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
The individual failed a 90-day trial of both of the following, as evidenced by paid claims or pharmacy printouts:
-
Praluent combined with rosuvastatin greater than or equal to 20 mg or atorvastatin greater than or equal to 40 mg;
and
- Nexlizet combined with rosuvastatin greater than or equal to 20 mg or atorvastatin greater than or equal to 40 mg.
Initial Authorization:
Six (6)
months
Reauthorization Criteria
Continuation of therapy with inclisiran (Leqvio) may be considered medically necessary when
ALL
of the following are met:
-
The individual has an LDL-C level less than 100 mg/dL or has achieved a 40% reduction;
and
- The individual must currently be receiving a maximally tolerated statin (HMG-CoA reductase inhibitor) agent, as evidenced by paid claims or pharmacy printouts.
Continuation Authorization: 12 months
Inclisiran (Leqvio) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. Scientific evidence does not support its efficacy or safety for any other indications.
Procedure Code
